a study of hs-20122 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a first-in-human (fih) phase i, multi-center, open-label, study of hs-20122, in patients with advanced solid tumors. this study will evaluate the safety, tolerability, pharmacokinetics and efficacy of hs-20122 in advanced solid tumors.


Eligibility criteria:
inclusion criteria: * males or females, aged ≥ 18 years. * subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors * standard treatment is invalid, unavailable or intolerable. * at least 1 target lesion according to recist 1.1. * ecog ps score: 0-1. * estimated life expectancy\> 12 weeks. * men or women should be using adequate contraceptive measures throughout the study. * women must have the evidence of non-childbearing potential. * signed and dated informed consent form. exclusion criteria: * any unresolved toxicities from prior therapy greater than grade 2 according to common terminology criteria for adverse events (ctcae) 5.0 with the exception of alopecia or neurotoxicity * history of other primary malignancies. * inadequate bone marrow reserve or organ dysfunction. * evidence of cardiovascular risk. * subjects with severe or poorly controlled diabetes. * subjects with severe or poorly controlled hypertension. * subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * subjects with severe arteriovenous thrombotic events within 3 months. * subjects with severe infection within 4 weeks prior to the first dose. * subjects who have received steroid therapy for more than 30 days . * presence of known active infectious diseases. * presence of clinically significant gastrointestinal dysfunction. * hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ child-pugh grade b. * moderate to severe pulmonary diseases. * prior history of significant neurological or mental disorders. * women who are breastfeeding or pregnant or planned to be pregnant during the study period. * hypersensitivity to any ingredient of hs-20122. * unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments any unresolved toxicities from prior therapy greater than grade 2 according to common terminology criteria for adverse events (ctcae) 5.0 with the exception of alopecia or neurotoxicity * history of other primary malignancies. * inadequate bone marrow reserve or organ dysfunction. * evidence of cardiovascular risk. * subjects with severe or poorly controlled diabetes. * subjects with severe or poorly controlled hypertension. * subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * subjects with severe arteriovenous thrombotic events within 3 months. * subjects with severe infection within 4 weeks prior to the first dose. * subjects who have received steroid therapy for more than 30 days . * presence of known active infectious diseases. * presence of clinically significant gastrointestinal dysfunction. * hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ child-pugh grade b. * moderate to severe pulmonary diseases. * prior history of significant neurological or mental disorders. * women who are breastfeeding or pregnant or planned to be pregnant during the study period. * hypersensitivity to any ingredient of hs-20122. * unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Keywords: advanced solid tumors hs-20122